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Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A

Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02175719
Collaborator
(none)
150
Enrollment
2
Locations
56.5
Actual Duration (Months)
75
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Apr 16, 2013
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Dec 31, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    E2014

    Outcome Measures

    Primary Outcome Measures

    1. Whole improvement level [Up to 1 year]

      Toronto Western Spasmodic Torticollis Scale (TWSTRS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    Patients with cervical dystonia who was treated by botulinum toxin type A in the past.

    Patients who was enrolled in NB01S and was evaluated by TWSTRS at the first injection of NerBloc.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka Japan
    2 Tokyo Japan

    Sponsors and Collaborators

    • Eisai Co., Ltd.

    Investigators

    • Study Director: Akira Endo, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02175719
    Other Study ID Numbers:
    • NB02T
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    Jul 11, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by Eisai Co., Ltd.
    Torticollis
    rimabotulinumtoxinB
    Additional relevant MeSH terms:
    Dystonia
    Torticollis

    Study Results

    No Results Posted as of Jul 11, 2018